Brand Name | MERIT CUSTOM KIT |
Type of Device | CUSTOM KIT |
Manufacturer (Section D) |
MERIT MEDICAL SYSTEMS, INC. |
1600 merit parkway |
south jordan UT 94095 |
|
Manufacturer (Section G) |
MERIT MEDICAL SYSTEMS, INC. |
1600 merit parkway |
|
south jordan UT 94095 |
|
Manufacturer Contact |
casey
hughes, ms, cqe, csqp
|
1600 merit parkway |
south jordan, UT 94095
|
8012531600
|
|
MDR Report Key | 6867439 |
MDR Text Key | 86589160 |
Report Number | 1721504-2017-00203 |
Device Sequence Number | 1 |
Product Code |
DQO
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,distri |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
08/21/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Service and Testing Personnel
|
Device Expiration Date | 01/31/2020 |
Device Catalogue Number | K12-MZT5201A |
Device Lot Number | H1071929 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
08/21/2017
|
Initial Date FDA Received | 09/14/2017 |
Supplement Dates Manufacturer Received | 09/14/2017
|
Supplement Dates FDA Received | 09/28/2017
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/06/2017 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|